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Letter to Congresswoman DeGette Expressing Concerns about 21st Century Cures

The Honorable Diana DeGette
United States House of Representatives
Washington, DC 20515

Dear Congresswoman DeGette,

As members of the Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, we are writing to express our concerns that you have not worked with us in your role as a leader in the 21st Century Cures project.

Knowing of our shared policy positions on a wide range of issues, it is very surprising to us that our perspectives have not been represented at the hearings thus far, or in the first white papers. Our organizations have been among the most active independent nonprofit organizations on FDA issues, and include major consumer, scientific and public health organizations. We want to be supportive of your efforts to work in a bipartisan manner to ensure that Americans have the best possible medical treatments, and to ensure that our perspectives as patients, consumers, physicians, scientists, and public health experts are reflected in the 21st Century Cures effort.

We are concerned about the direction these discussions are taking. In its first white paper, the committee states that it is “soliciting ideas on how Congress can help accelerate the discovery, development, and delivery of promising new treatments to patients.” The white paper focuses on speeding approvals of medical products without paying adequate attention to making sure that FDA’s essential safeguards are protected for men, women, children, and regarding prenatal exposures.

We request that future discussions include representatives from our Coalition. We believe that we bring an essential perspective and valuable expertise.

We look forward to working with you more closely as these discussions move forward.